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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031530
Receipt No. R000035842
Scientific Title A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Date of disclosure of the study information 2018/03/01
Last modified on 2019/09/01

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Basic information
Public title A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Acronym A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Scientific Title A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Scientific Title:Acronym A clinical study for robotic-assisted hysterectomy with da Vinci Surgical System
Region
Japan

Condition
Condition Uterine fibroids
Uterine adenomyosis
Uterine prolapse
Otherwise benign uterine disease
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of robotic assisted hysterecomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total operating time
Key secondary outcomes Console time
Amount of bleeding during the operation
Intraoperative complications
Postoperative complications
Hospital days

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Robotic assisted hysterectomy performed with da Vinci surgical system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Female
Key inclusion criteria 1) Patients who have benign uterine disease for which hysterectomy is indicated.
2) Patient's BMI is lower than 35.
3) Patient's function of major organs (bone marrow, heart, lung, liver and kidneys) is good and suitable for the operation.
4) Patients who have received full explanations about the contents of the study and agreed to participate in the study, and who have submitted a written consent agreement.
Key exclusion criteria 1) Patients who have experienced more than three times of laparotomy.
2) Patients who have severe endometriosis.
3) Patients who have the uterus more than 15cm in diameter.
4) Patients who have mental disease or mental symptoms, difficult to participate to the study.
5) Patients who have brain aneurysm or glaucoma.
6) Patients who are judged ineligible by the principal investigator or sub-investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Osamu
Middle name
Last name Nishii
Organization University Hospital, Mizonokuchi, Teikyo University School of Medicine
Division name Obstetrics and Gynecology
Zip code 213-0002
Address 5-1-1, Futago, Takatsu-ku, Kawasaki City, Kanagawa
TEL 044-844-3333
Email nishii@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Tsuchiya
Organization University Hospital, Mizonokuchi, Teikyo University School of Medicine
Division name Obstetrics and Gynecology
Zip code 213-0002
Address 5-1-1, Futago, Takatsu-ku, Kawasaki City, Kanagawa
TEL 044-844-3333
Homepage URL
Email tsuchiya@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee, Teikyo University
Address 2-11-1 Kaga Itabashi-ku Tokyo Japan
Tel 03-3964-7256
Email turb-office@teikyo-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 02 Month 22 Day
Date of IRB
2018 Year 02 Month 22 Day
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
2028 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 01 Day
Last modified on
2019 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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